Moon Surgical obtains FDA nod for commercial soft tissue robot

Moon Surgical has gained FDA clearance to market its Maestro soft tissue surgical robot commercially in the U.S., challenging Intuitive Surgical’s da Vinci system dominance. Based in Paris and San Francisco, Moon is among many new players entering the growing robotic surgery market.

Their plan involves a limited launch of the Maestro system in the U.S. and Europe before a broader rollout in 2025. Moon aims to fill a gap in laparoscopic surgeries currently unsuitable for traditional robot-assisted devices, estimating around 19 million additional soft tissue surgical procedures yearly could benefit.

The Maestro robot, adaptable to existing clinical workflows, promises to improve operating room efficiency. With a CE mark obtained in September 2023, the system has treated over 200 patients across two European pilot sites. Moon had previously gained FDA clearance for a noncommercial version of Maestro in December 2022.

Joining other robot manufacturers in the soft tissue surgery market, Moon follows Medical Microinstruments and Virtual Incision, who received FDA de novo classifications for their Symani and Mira systems, respectively.